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What is Drug Labeling?

In the U.S., all products are required to have accompanying warning labels informing consumers of any known and potential dangers associated with the product. For drugs, these requirements are even more stringent due to the risks of taking medicines. This is true of both prescription and over-the-counter drugs.

The U.S. Food and Drug Administration (FDA) is responsible for approving any labels that accompany drugs and medical products. Also, sellers and distributors of a drug product are generally under obligation to warn consumers of any unique risks. Drug labels should contain information such as ingredients, dosages, number of units per package, safety concerns, and other information.

What are Some Dangers Associated With Drug Labels?

An unsafe drug may be considered unsafe not only due to the contents of the drug, but due to the way that it’s packaged. Drug labeling lawsuits may arise if a particular drug is not accompanied by the appropriate labels. Some violations may include:

Wrong information posted on the label

Errors or mistakes with regard to dosages and instructions

Complete failure to include any type of label

Mislabeling of the product (for instance, if labels were accidentally switched)

Such issues can pose great risks to the consumer, and violations may result in stiff penalties for the defendant. In a drug labeling lawsuit, the plaintiff may be able to recover a damages award if they can prove that the drug company (or distributor) was negligent with regards to a drug label.

What are “Off-Label” Drugs?

Off label drugs are any drugs that haven’t been approved by the FDA. These can still be sold, but they too must have the appropriate labels that are needed. Off-label drugs are sometimes recommended as a cheaper alternative to taking a prescription medicine. However, if a doctor recommends such an alternative, they also need to explain why it’s ok to do so, and where there are any additional risks or concerns in doing so.

Do I Need a Lawyer for Assistance With a Drug Labeling Lawsuit?

Drug labeling lawsuits may involve complex laws at both the state and federal levels. You may need to hire a lawyer in your area if you need help filing a drug labeling lawsuit. Your attorney will be able to advise you on the laws in your region, and can inform you if there are any particular concerns or issues with a specific drug.